Cleared Traditional

DISPOSABLE SPECIALITY SPONGES

K791870 · Carwild Corp. · General & Plastic Surgery
Nov 1979
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K791870 is an FDA 510(k) clearance for the DISPOSABLE SPECIALITY SPONGES, a Dissector, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDI), submitted by Carwild Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979, 45 days after receiving the submission on September 21, 1979. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K791870 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1979
Decision Date November 05, 1979
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDI — Dissector, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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